中成药治疗射血分数保留的心力衰竭临床研究证据图分析

Evidence map analysis of clinical research on treatment of heart failure with preserved ejection fraction with proprietary Chinese medicines

关键词:  中成药  射血分数保留的心力衰竭  证据图  临床研究  方法学质量评价

Key words:  proprietary Chinese medicines  heart failure with preserved ejection fraction  evidence map  clinical study  methodological quality assessment

摘要:

[目的] 该研究旨在通过构建证据图，对现有中成药治疗射血分数保留的心力衰竭（HFpEF）临床研究进行综合分析，系统评估现有证据的有效性和局限性，为后续临床研究提供科学依据。[方法] 系统检索了7个数据库，检索时限均从建库至2025年5月，对纳入文献的临床研究特征和方法学质量进行评价。[结果] 最终纳入177篇文献，其中随机对照试验（RCT）166篇，二次研究10篇，专家共识1篇。涉及35种中成药，其中芪苈强心胶囊应用最广泛，多数研究周期在2~4周，样本量51~100例，常与西药联合治疗，主要结局指标包括总有效率、心功能指标、安全性指标等，方法学质量评价方面，RCT存在随机化及结局指标测量的偏倚，并有选择性报告的风险。Meta分析则在研究方案注册、排除文献清单列举、利益冲突披露等方面报告不足，网状Meta分析评价指标较少，不同文献之间结果差异较大。专家共识被评价为修订后推荐，推荐了5种中成药，目前证据级别较低。[结论] 中成药治疗HFpEF临床研究证据质量亟待提高，急需开展大样本长周期随机对照试验，进一步深化证型和疗效的关联，为中医治疗射血分数保留的心力衰竭提供更多的循证依据和临床实践方案。

Abstract:

[Objective]The aim of this study was to synthesize and analyze existing clinical studies on proprietary Chinese medicines for the treatment of heart failure with preserved ejection fraction(HFpEF)by constructing an evidence map. The validity and limitations of the existing evidence were systematically assessed to provide a scientific basis for subsequent clinical studies.[Methods]Seven databases were systematically searched, all with a search timeframe from the establishment of the database to May 2025, to evaluate the clinical study characteristics and methodological quality of the included literature.[Results]Finally, 177 literatures were included, including 166 interventional studies, 10 secondary studies, and 1 expert consensus. Thirty-five proprietary Chinese medicines were involved, with Qili Qiangxin Capsules being the most widely used. Most of the studies had a period of 2 weeks to 4 weeks and a sample size of 51~100 cases. Most trial groups were often combined with Western medicine. The main outcome indicators include total effective rate, cardiac function indicators, safety indicators. Regarding the evaluation of methodological quality, randomized controlled trials had bias in randomization and measurement of endpoint indicators, and were at risk of selective reporting. Meta-analysis, on the other hand, reported inadequacies in the registration of study protocols, enumeration of the list of excluded literature, and disclosure of conflicts of interest, with fewer evaluation indicators for reticulation Meta-analysis, and large variations in the results between different literatures. The expert consensus was evaluated as recommended after revision. It recommended five proprietary Chinese medicines, which currently have a low level of evidence.[Conclusion]The quality of clinical research evidence on proprietary Chinese medicines for HFpEF needs to be improved. There is an urgent need for large-sample, long-period randomized controlled trials to further deepen the association between evidence and efficacy. In order to provide more evidence-based and clinical practice protocols for traditional Chinese medicine treatment of HFpEF.